The Orthopedic Technology Evidence Index

What is cleared—and what has actually been studied.

This index pairs public FDA records for spine-related AI devices with human studies, active trials, recalls, and the limitations tied to the same function. For clinicians, researchers, trainees, and health-technology teams.

17device families meeting current criteria

4technology categories

Quarterlyplanned verification

Aug 24, 2026research cutoff

Explore the index

Start with the regulatory record.

17 of 17 platform families shown

Web software for measurements, surgical strategy simulation, patient-specific rod and implant planning, and estimation of compensatory alignment effects. The current v5.1 record is a Special 510(k) predicated on K251629.

Evidence snapshot

FDA materials describe retrospective validation of the current Analyzer’s predictive functions. The linked studies evaluate the broader UNiD workflow, not the exact cleared AI, and do not raise the exact-function stage. An open Class II recall in predecessor/family record K212005 concerned optional calculation outputs; a correction was released December 3, 2024.

alignmentsurgical planningrecall

510(k) review panel: Radiology
Product code: QIH / LLZ
Predicate: UNiD Spine Analyzer · K251629
Cleared-function match: Partial
Evidence independence: FDA-only
Safety: Open Class II predecessor/family recall
Last checked: Aug 24, 2026

FDA record ↗Clearance summary ↗Recall record ↗Indirect 86-patient UNiD cohort ↗Indirect case-matched UNiD study ↗Indirect 20-patient UNiD study ↗Indirect terminated UNiD registry ↗

Authorization / AI ambiguity

Tracked separately pending clarification.

Public records do not clearly identify which authorized function is AI-enabled.

Verification watchlist

Paradigm System

Proprio · K252950

The FDA summary describes CT segmentation, 3D modeling, topographic registration, navigation, and pedicle-cannulation support without identifying AI/ML. The device was not located on the current FDA AI-enabled list; manufacturer AI claims alone do not meet the inclusion rule.

Review FDA source ↗

Verification watchlist

xvision Spine System

Augmedics · K251639

K251639 appears on the FDA AI-enabled device list, but the public 510(k) summary describes augmented-reality navigation and tracking changes without identifying which authorized function is AI-enabled.

Review FDA source ↗

A deliberately narrow method

How entries are included and staged.

Identify

Find spine-relevant entries in FDA authorization records and group iterative submissions into platform families.

Verify

Confirm the cleared function, regulatory pathway, product code, and intended clinical use from primary documents.

Connect

Link up to three key human studies, active trials, recalls, and postmarket sources to the exact function evaluated.

Stage

Report the highest evidence stage reached without ranking products or implying that clearance equals clinical superiority.

0Regulatory record onlyClearance plus bench or non-human testing; no human clinical validation located.1Human performance validationHuman data appear in FDA materials; no peer-reviewed study of the exact function located.2Clinical validityPeer-reviewed human evidence evaluates the exact or a materially matching function.3Clinical utilityEvidence evaluates effects on clinician performance, workflow, or decision-making.4Comparative patient outcomesProspective comparative evidence evaluates meaningful patient outcomes.

The stage reports the highest evidence type located. It is not a product ranking or an overall quality score.

Interpret with care

Transparent about what the data cannot say.

The FDA describes its AI-enabled device list as noncomprehensive. Inclusion here requires a spine-relevant authorized use plus an FDA record that explicitly identifies AI/ML, or a QIH classification with a trained algorithm described in the summary.

“No exact-K-associated recall located” does not mean no adverse events or product-code safety signals. MAUDE reports are surveillance signals—not incidence estimates, proof of causation, or a basis for comparing products.

Manufacturer claims, FDA-authorized functions, and independent published findings are kept separate. Evidence independence is labeled Independent, Mixed, Manufacturer-linked, or FDA-only.

This is a curated index, not a formal systematic review. Information may be incomplete or become outdated; verify material decisions against the linked primary sources.